Levetiracetam 1A Pharma 100 mg/ml drank, drank

Do not take Levetiracetam 1 A Pharma

• If you are allergic ( hypersensitive) to levetiracetam or any of the other ingredients of Levetiracetam 1 A Pharmathis medicine (listed in section 6).

Warnings and precautions

Talk to your doctor before taking Levetiracetam 1 A Pharma

• If you suffer from kidney problems, follow your doctor’s instructions. He/she may decide if your dose should be adjusted.

• If you notice any slow down in the growth or unexpected puberty development of your child, please contact your doctor.
• If you notice an increase in seizure severity (e.g. increased number), please contact your doctor.
• A small number of people being treated with anti-epileptics such as Levetiracetam 1 A Pharma have had thoughts of harming or killing themselves. If you have any symptoms of depression and/or suicidal ideation, please contact your doctor.

Other medicines and [nationally completed name]

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Levetiracetam 1 A Pharma with food, drink and alcohol

You may take Levetiracetam 1 A Pharma with or without food. As a safety precaution, do not take Levetiracetam 1 A Pharma with alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

If you are pregnant or if you think you may be pregnant, please inform your doctor. Levetiracetam 1 A Pharma should not be used during pregnancy unless clearly necessary. The potential risk to your unborn child is unknown. Levetiracetam has shown unwanted reproductive effects in animal studies at dose levels higher than you would need to control your seizures.

Breast-feeding is not recommended during treatment.

Driving and using machines

Levetiracetam 1 A Pharma may impair your ability to drive or operate any tools or machinery, as Levetiracetam 1 A Pharma may make you feel sleepy. This is more likely at the beginning of treatment or after an increase in the dose. You should not drive or use machines until it is established that your ability to perform such activities is not affected.

Levetiracetam 1 A Pharmacontains parahydroxybenzoate and maltitol

Levetiracetam 1 A Pharma contains methyl parahydroxybenzoate (E218) which may cause allergic reactions. (possibly delayed).

Levetiracetam 1 A Pharma also contains maltitol liquid (E965). If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Always take Levetiracetam 1 A Pharmathis medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Levetiracetam 1 A Pharma must be taken twice a day, once in the morning and once

in the evening, at about the same time each day. Take the oral solution following your doctor’s instructions.

Monotherapy

Dose in adults and adolescents (from 16 years of age) :

General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day, divided in 2 intakes per day.

When you will first start taking Levetiracetam 1 A Pharma, your doctor will prescribe you a lower dose during 2 weeks before giving you the lowest general dose.

Add-on therapy

Dose in adults and adolescents (12 to 17 years) weighing 50 kg or more:

General dose: between 10 ml (1,000 mg) and 30 ml (3,000 mg) each day divided in 2 intakes per day.

Dose in infants (6 to 23 months), children (2 to 11 years) and adolescents (12 to 17 years) weighing less than 50 kg:

Your doctor will prescribe the most appropriate pharmaceutical form of levetiracetam according to the age, weight and dose.

General dose: between 0.2 ml (20 mg) and 0.6 ml (60 mg) per kg bodyweight each day, divided in 2 intakes per day.

The exact quantity of oral solution formulation should be delivered using the syringe provided in the cardboard box.

Weight	Starting dose: 0.1 ml/kg twice	Maximum dose: 0.3 ml/kg
	daily	twice daily
6 kg	0.6 ml twice daily	1.8 ml twice daily
8 kg	0.8 ml twice daily	2.4 ml twice daily
10 kg	1 ml twice daily	3 ml twice daily
15 kg	1.5 ml twice daily	4.5 ml twice daily
20 kg	2 ml twice daily	6 ml twice daily
25 kg	2.5 ml twice daily	7.5 ml twice daily
From 50 kg	5 ml twice daily	15 ml twice daily

Dose in infants (1 month to less than 6 months):

General dose: between 0.14 ml (14 mg) and 0.42 ml (42 mg) per kg bodyweight each day, divided in 2 intakes per day. The exact quantity of oral solution formulation should be delivered using the syringe provided in the cardboard box.

Method of administration:

Levetiracetam 1 A Pharma may be diluted in a glass of water or baby’s bottle

.

Instructions for use:

• Open the bottle : press the cap and turn it anticlockwise (figure 1)
• Separate the adaptor from the syringe (figure 2) Insert the adaptor into the bottle neck. Ensure it is well fixed.
• Take the syringe and put it in the adaptor opening. Turn the bottle upside down (figure 3)
• Fill the syringe with a small amount of solution by pulling the piston down (figure 4 a), then push the piston upward in order to remove any possible bubble (figure 4 b) Pull the piston down to the graduation mark corresponding to the quantity in milliliters (ml) prescribed by your doctor (figure 4 c).
• Turn the bottle the right way up. Remove the syringe from the adaptor.
• Empty the contents of the syringe in a glass of water or baby’s bottle by pushing the piston to the bottom of the syringe (figure 5).
• Drink the whole contents of the glass/baby’s bottle.
• Close the bottle with the plastic screw cap.
• Wash the syringe with water (figure 6)

Duration of treatment:

• Levetiracetam 1 A Pharma is used as a chronic treatment. You should continue Levetiracetam 1 A Pharma treatment for as long as your doctor has told you.
• Do not stop your treatment without your doctor’s advice as this could increase your seizures. Should your doctor decide to stop your Levetiracetam 1 A Pharma treatment, he/she will instruct you about the gradual withdrawal of Levetiracetam 1 A Pharma.

If you take more Levetiracetam 1 A Pharma than you should

The possible side effects of an overdose of Levetiracetam 1 A Pharmaare sleepiness, agitation, aggression, decrease of alertness, inhibition of breathing and coma. Contact your doctor if you took more than you should.

Your doctor will establish the best possible treatment of overdose.

If you forget to take Levetiracetam 1 A Pharma

Contact your doctor if you have missed one or more doses.

Do not take a double dose to make up for a forgotten dose.

If you stop taking Levetiracetam 1 A Pharma

If stopping treatment, as with other antiepileptic medicines, Levetiracetam 1 A Pharma should be discontinued gradually to avoid an increase of seizures.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Like all medicines, Levetiracetam 1 A Pharmathis medicine can cause side effects, although not everybody gets them.

Some of the side effects like sleepiness, tiredness and dizziness may be more common at the beginning of the treatment or at dose increase. These effects should however decrease over time.

Very common: may affect more than 1 user in 10

• nasopharyngitis;
• somnolence (sleepiness), headache.

Common: may affect 1 to 10 users in 100

• anorexia (loss of appetite);
• depression, hostility or aggression, anxiety, insomnia, nervousness or irritability;
• convulsion, balance disorder (equilibrium disorder), dizziness (sensation of unsteadiness), lethargy, tremor (involuntary trembling);
• vertigo (sensation of rotation);
• cough;
• abdominal pain, diarrhoea, dyspepsia (indigestion), vomiting, nausea;
• rash;
• asthenia/fatigue (tiredness).

Uncommon: may affect 1 to 10 users in 1000

• decreased number of blood platelets, decreased number of white blood cells;
• weight decrease, weight increase;
• suicide attempt and suicidal ideation, mental disorder, abnormal behaviour, hallucination, anger, confusion, panic attack, emotional instability/mood swings, agitation;
• amnesia (loss of memory), memory impairment (forgetfulness), abnormal coordination/ataxia (impaired coordinated movements), paraesthesia (tingling), disturbance in attention (loss of concentration);
• diplopia (double vision), vision blurred;
• liver function test abnormal;
• hair loss, eczema, pruritus;
• muscle weakness, myalgia (muscle pain);
• injury.

Rare: may affect 1 to 10 users in 10,000

• infection;
• decreased number of all blood cell types;
• suicide, personality disorders (behavioural problems), thinking abnormal (slow thinking, unable to concentrate);
• uncontrollable muscle spasms affecting the head, torso and limbs, difficulty in controlling movements, hyperkinesia (hyperactivity);
• pancreatitis;
• hepatic failure, hepatitis;
• skin rash, which may form blisters and looks like small targets (central dark spots surrounded by a paler area, with a dark ring around the edge) (erythema multiforme), a widespread rash with blisters and peeling skin, particularly around the mouth, nose, eyes and genitals (Stevens– Johnson syndrome), and a more severe form causing skin peeling in more than 30% of the body surface (toxic epidermal necrolysis).

If you get any side effects, talk to your doctor or pharmacist. This includes any side effects not listed in this leaflet.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the carton box and bottle after EXP:

The expiry date refers to the last day of the month. Do not use after 4 months of first opening the bottle.

Store in the original container in order to protect from light.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Levetiracetam 1A Pharma 100 mg/ml contains:

The active substance is called Levetiracetam. The other ingredients are:

Sodium citrate (for pH adjustment), Citric acid monohydrate (for pH adjustment), Methyl parahydroxybenzoate (E218), Glycerol (E422), Acesulfame potassium (E950), Maltitol liquid (E965), Raspberry liquid, Purified water

What Levetiracetam 1A Pharma 100 mg/ml looks like and the contents of the pack

Levetiracetam 1A Pharma 100 mg/ml oral solution is a clear liquid

The 300 ml glass bottle of Levetiracetam 1A Pharma 100 mg/ml(for children aged 4 years and above, adolescents and adults) is packed in a cardboard box containing a graduated oral syringe of 10 ml graduated 0.25 ml per 0.25 ml and an adaptor for the syringe.

The 150 ml glass bottle of Levetiracetam 1A Pharma 100 mg/ml(for infants aged 6 months and above and children aged 2 to 4 years) is packed in a cardboard box containing a graduated oral syringe of 3 ml graduated 0.1 ml per 0.1 ml and an adaptor for the syringe.

The 150 ml glass bottle of Levetiracetam 1A Pharma 100 mg/ml (for infants aged 1 month to less than 6 months) is packed in a cardboard box containing a graduated oral syringe of 0.05 ml per 0.05 ml and an adaptor for the syringe.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

1A PHARMA GmbH

Keltenring 1 + 3

82041 Oberhaching

Duitsland

Manufacturer

Remedica Ltd

Limassol Industrial Estate

P.O. Box 51706

CY-3508 Limassol

Cyprus

Lek Pharmaceuticals d.d. Verovškova 57

1526 Ljubljana Slovenië

Lek Pharmaceuticals d.d. Trimlini 2D

9220 Lendava Slovenië

LEK S.A.

ul. Domaniewska 50 C 02-672 Warschau Polen

Salutas Pharma GmbH

Otto-von-Guericke Allee 1

39179 Barleben

Duitsland

Salutas Pharma GmbH

Dieselstrasse 5

70839 Gerlingen

Duitsland

S.C. Sandoz, S.R.L.

Str. Livezeni nr. 7A

RO-540472 Targu-Mures

Roemenië

RVG 108552

This medicines product is authorised in the Member States of the EEA under the following names:

NL: Levetiracetam 1A Pharma 100 mg/ml, drank

DE: Levetiracetam – 1 A Pharma 100 mg/ml Lösung zum Einnehmen

This leaflet was last approved in November 2012.